FLUDARA Side Effects

6998446-0 | Pyrexia, Renal Failure Acute
on Sep 10, 2010 Male patient from UNITED STATES , 64 years of age, weighting 198.4 lb, was diagnosed with chronic lymphocytic leukaemia, pyrexia and was treated with Fludara (View Usage). Patient experienced the following unwanted or unexpected effects: pyrexia, renal failure acute. Fludara dosage: . During the same period patient was treated with TAZOCIN (Total Daily Dose: 18 G) (View Tazocin Review and Tazocin Label ), TRITACE (View Tritace Review and Tritace Label ), HERPLEX (View Herplex Review and Herplex Label ), SINERSUL (View Sinersul Review and Sinersul Label ), AMONEX (View Amonex Review and Amonex Label ). Patient was hospitalized.

6969911-7 | Engraft Failure, Epstein-barr Virus Associated Lymphoproliferative Disorder, Liver Disorder, Platelet Count Decreased, Pyrexia, Serum Ferritin Increased
Patient was taking Fludara (View Usage). Patient had the following side effects: engraft failure, epstein-barr virus associated lymphoproliferative disorder, liver disorder, platelet count decreased, pyrexia, serum ferritin increased on Aug 24, 2010 from JAPAN Additional patient health information: Male patient , 24 years of age, weighting 160.9 lb, was diagnosed with aplastic anaemia and. Fludara dosage: . During the same period patient was treated with THYMOGLOBULIN (View Thymoglobulin Review and Thymoglobulin Label ), CYCLOPHOSPHAMIDE (View Cyclophosphamide Review and Cyclophosphamide Label ), CYCLOSPORINE (View Cyclosporine Review and Cyclosporine Label ), METHYLPREDNISOLONE SODIUM SUCCINATE (View Methylprednisolone Sodium Succinate Review and Methylprednisolone Sodium Succinate Label ), MEROPENEM TRIHYDRATE (View Meropenem Trihydrate Review and Meropenem Trihydrate Label ), VANCOMYCIN HCL (View Vancomycin Hcl Review and Vancomycin Hcl Label ), LANSOPRAZOLE (View Lansoprazole Review and Lansoprazole Label ), VALACYCLOVIR (View Valacyclovir Review and Valacyclovir Label ). Patient was hospitalized.

6968191-6 | Acute Myocardial Infarction, Ascites, Dyspnoea, Mucosal Inflammation, Pleural Effusion, Pneumonia, Pyrexia, Renal Failure, Respiratory Failure
Adverse event was reported on Aug 31, 2010 by a Female patient taking Fludara (View Usage) (Dosage: X 4 Days) was diagnosed with acute myeloid leukaemia and. Location: UNITED STATES , 32 years of age, After Fludara was administered, patient had the following side effects: acute myocardial infarction, ascites, dyspnoea, mucosal inflammation, pleural effusion, pneumonia (What is pneumonia?), pyrexia, renal failure, respiratory failure. During the same period patient was treated with NEUPOGEN (X 6 Days) (View Neupogen Review and Neupogen Label ), PLERIXAFOR (X 4 Days) (View Plerixafor Review and Plerixafor Label ), BUSULFAN (X 4 Days) (View Busulfan Review and Busulfan Label ), ANTI THYMOCYTE GLOBULIN NOS (X 1 Day) (View Anti-thymocyte Globulin Nos Review and Anti-thymocyte Globulin Nos Label ), ANTI THYMOCYTE GLOBULIN NOS (X 1 Day) (View Anti-thymocyte Globulin Nos Review and Anti-thymocyte Globulin Nos Label ), ANTI THYMOCYTE GLOBULIN NOS (X 1 Day) (View Anti-thymocyte Globulin Nos Review and Anti-thymocyte Globulin Nos Label ), ACETAMINOPHEN (Q 4 Hrs) (View Acetaminophen Review and Acetaminophen Label ), ALBUMIN (HUMAN) (Total Daily Dose: 100 G) (View Albumin (human) Review and Albumin (human) Label ). Patient was hospitalized.

6967905-9 | Pyrexia, Renal Failure Acute
on Sep 02, 2010 Male patient from UNITED STATES , 64 years of age, weighting 198.4 lb, was diagnosed with chronic lymphocytic leukaemia, pyrexia and was treated with Fludara (View Usage). Patient experienced the following unwanted or unexpected effects: pyrexia, renal failure acute. Fludara dosage: . During the same period patient was treated with TAZOCIN (Total Daily Dose: 18 G) (View Tazocin Review and Tazocin Label ), TRITACE (View Tritace Review and Tritace Label ), HERPLEX (View Herplex Review and Herplex Label ), SINERSUL (View Sinersul Review and Sinersul Label ), AMONEX (View Amonex Review and Amonex Label ). Patient was hospitalized.


6905697-X | Arrhythmia, Asthenia, Decreased Appetite, Dilatation Ventricular, Leukopenia, Loss Of Consciousness, Upper Respiratory Tract Infection
on Jul 23, 2010 Female patient from CZECH REPUBLIC , 76 years of age, was diagnosed with chronic lymphocytic leukaemia and was treated with Fludara (View Usage). Patient had the following side effects: arrhythmia (What is arrhythmia?), asthenia, decreased appetite, dilatation ventricular, leukopenia, loss of consciousness, upper respiratory tract infection. Fludara dosage: . During the same period patient was treated with MABTHERA (View Mabthera Review and Mabthera Label ), CYCLOPHOSPHAMIDE (View Cyclophosphamide Review and Cyclophosphamide Label ), EUTHYROX 50 (View Euthyrox 50 Review and Euthyrox 50 Label ), NITROMINT AER (View Nitromint Aer Review and Nitromint Aer Label ), HELICID (View Helicid Review and Helicid Label ), NITROFURANTOIN (View Nitrofurantoin Review and Nitrofurantoin Label ), MAGNOSOLV (View Magnosolv Review and Magnosolv Label ). Patient was hospitalized.

6883817-3 | Ascites, Dyspnoea, Mucosal Inflammation, Pleural Effusion, Pneumonia, Pyrexia, Renal Failure, Stomatitis, Venoocclusive Disease
Patient was taking Fludara (View Usage). After Fludara was administered, patient had the following side effects: ascites, dyspnoea, mucosal inflammation, pleural effusion, pneumonia (What is pneumonia?), pyrexia, renal failure, stomatitis, venoocclusive disease on Jul 19, 2010 from UNITED STATES Additional patient health information: Female patient , 31 years of age, was diagnosed with acute myeloid leukaemia and. Fludara dosage: X 4 Days. During the same period patient was treated with NEUPOGEN (X 6 Days) (View Neupogen Review and Neupogen Label ), PLERIXAFOR (X 4 Days) (View Plerixafor Review and Plerixafor Label ), BUSULFAN (X 4 Days) (View Busulfan Review and Busulfan Label ), ANTI THYMOCYTE GLOBULIN NOS (X 1 Day) (View Anti-thymocyte Globulin Nos Review and Anti-thymocyte Globulin Nos Label ), ANTI THYMOCYTE GLOBULIN NOS (X 1 Day) (View Anti-thymocyte Globulin Nos Review and Anti-thymocyte Globulin Nos Label ), ANTI THYMOCYTE GLOBULIN NOS (X 1 Day) (View Anti-thymocyte Globulin Nos Review and Anti-thymocyte Globulin Nos Label ), ACETAMINOPHEN (Q 4 Hrs) (View Acetaminophen Review and Acetaminophen Label ), ALBUMIN (HUMAN) (Total Daily Dose: 100 G) (View Albumin (human) Review and Albumin (human) Label ). Patient was hospitalized.

6878921-X | Coordination Abnormal, Dizziness, Headache
Adverse event was reported on Jul 19, 2010 by a Male patient taking Fludara (View Usage) (Dosage: 1 Every 5 Days Repeat Every 28 Days) was diagnosed with hairy cell leukaemia and. Location: CANADA , 49 years of age, weighting 178.6 lb, Patient experienced the following unwanted or unexpected effects: coordination abnormal, dizziness (What is dizziness?), headache (What is headache?).

6875949-0 | Adenovirus Infection, Cytomegalovirus Viraemia, Hepatitis Fulminant
on Jul 20, 2010 Female patient from JAPAN , 58 years of age, was treated with Fludara (View Usage). Patient had the following side effects: adenovirus infection, cytomegalovirus viraemia, hepatitis fulminant. Fludara dosage: . During the same period patient was treated with THYMOGLOBULIN (View Thymoglobulin Review and Thymoglobulin Label ), CYCLOPHOSPHAMIDE (View Cyclophosphamide Review and Cyclophosphamide Label ).

6856694-4 | Ascites, Dyspnoea, Mucosal Inflammation, Pleural Effusion, Pneumonia, Pyrexia, Stomatitis, Venoocclusive Disease
on Jul 09, 2010 Female patient from UNITED STATES , 31 years of age, was diagnosed with acute myeloid leukaemia and was treated with Fludara (View Usage). After Fludara was administered, patient had the following side effects: ascites, dyspnoea, mucosal inflammation, pleural effusion, pneumonia (What is pneumonia?), pyrexia, stomatitis, venoocclusive disease. Fludara dosage: X 4 Days. During the same period patient was treated with NEUPOGEN (X 6 Days) (View Neupogen Review and Neupogen Label ), PLERIXAFOR (X 4 Days) (View Plerixafor Review and Plerixafor Label ), BUSULFAN (X 4 Days) (View Busulfan Review and Busulfan Label ), ANTI THYMOCYTE GLOBULIN NOS (X 1 Day) (View Anti-thymocyte Globulin Nos Review and Anti-thymocyte Globulin Nos Label ), ANTI THYMOCYTE GLOBULIN NOS (X 1 Day) (View Anti-thymocyte Globulin Nos Review and Anti-thymocyte Globulin Nos Label ), ANTI THYMOCYTE GLOBULIN NOS (X 1 Day) (View Anti-thymocyte Globulin Nos Review and Anti-thymocyte Globulin Nos Label ), ACETAMINOPHEN (Q 4 Hrs) (View Acetaminophen Review and Acetaminophen Label ), ALBUMIN (HUMAN) (Total Daily Dose: 100 G) (View Albumin (human) Review and Albumin (human) Label ). Patient was hospitalized.

6856609-9 | Acute Respiratory Failure, Anaemia, Cytomegalovirus Infection, Cytomegalovirus Test Positive, Febrile Neutropenia, Liver Disorder, Neutrophil Count Decreased, Platelet Count Decreased
Patient was taking Fludara (View Usage). Patient experienced the following unwanted or unexpected effects: acute respiratory failure, anaemia, cytomegalovirus infection (What is cytomegalovirus infection?), cytomegalovirus test positive, febrile neutropenia, liver disorder, neutrophil count decreased, platelet count decreased on Jul 07, 2010 from JAPAN Additional patient health information: Male patient , 59 years of age, weighting 132.3 lb, was diagnosed with stem cell transplant, prophylaxis against graft versus host disease, antifungal prophylaxis, depression (What is depression?), prophylaxis against gastrointestinal ulcer, antiviral prophylaxis and. Fludara dosage: . During the same period patient was treated with THYMOGLOBULIN (View Thymoglobulin Review and Thymoglobulin Label ), BUSULFAN (View Busulfan Review and Busulfan Label ), TACROLIMUS (View Tacrolimus Review and Tacrolimus Label ), METHOTREXATE (View Methotrexate Review and Methotrexate Label ), FLUCONAZOLE (View Fluconazole Review and Fluconazole Label ), SULPIRIDE (View Sulpiride Review and Sulpiride Label ), LANSOPRAZOLE (View Lansoprazole Review and Lansoprazole Label ), ACYCLOVIR (View Acyclovir Review and Acyclovir Label ). Patient was hospitalized.

6819284-5 | Altered State Of Consciousness, Non-hodgkin's Lymphoma
Adverse event was reported on Jun 29, 2010 by a Male patient taking Fludara (View Usage) (Dosage: ) was diagnosed with lymphoplasmacytoid lymphoma/immunocytoma stage iv, altered state of consciousness and. Location: JAPAN , 57 years of age, Patient had the following side effects: altered state of consciousness, non-hodgkin's lymphoma. During the same period patient was treated with RITUXAN (View Rituxan Review and Rituxan Label ), DECADRON (View Decadron Review and Decadron Label ).

6812032-4 | Disseminated Intravascular Coagulation
on Jun 28, 2010 Female patient from JAPAN , child 9 years of age, was diagnosed with acute myeloid leukaemia and was treated with Fludara (View Usage). After Fludara was administered, patient had the following side effects: disseminated intravascular coagulation. Fludara dosage: . During the same period patient was treated with CYTARABINE (View Cytarabine Review and Cytarabine Label ), IDARUBICIN HCL (View Idarubicin Hcl Review and Idarubicin Hcl Label ). Patient was hospitalized.

6809292-2 | Anal Fistula, Lymphocyte Count Decreased, Neutrophil Count Decreased, Rash
on Jun 18, 2010 Male patient from JAPAN , 55 years of age, was diagnosed with follicle centre lymphoma, follicular grade i, ii, iii stage iv and was treated with Fludara (View Usage). Patient experienced the following unwanted or unexpected effects: anal fistula, lymphocyte count decreased, neutrophil count decreased, rash (What is rash?). Fludara dosage: Unit Dose: 10 Mg. During the same period patient was treated with RITUXAN (View Rituxan Review and Rituxan Label ), NOVANTRONE (View Novantrone Review and Novantrone Label ). Patient was hospitalized.

6800997-6 | Neutrophil Count Decreased, Platelet Count Decreased, Renal Failure, Renal Impairment
Patient was taking Fludara (View Usage). Patient had the following side effects: neutrophil count decreased, platelet count decreased, renal failure, renal impairment on Jun 23, 2010 from JAPAN Additional patient health information: Female patient , 70 years of age, was diagnosed with hyperuricaemia, antifungal prophylaxis, gastric ulcer, renal failure chronic, cancer pain, osteoporosis (What is osteoporosis?) and. Fludara dosage: . During the same period patient was treated with ZYLORIC (View Zyloric Review and Zyloric Label ), COTRIM (View Cotrim Review and Cotrim Label ), ITRIZOLE (View Itrizole Review and Itrizole Label ), PROTECADIN (View Protecadin Review and Protecadin Label ), LASIX (View Lasix Review and Lasix Label ), ALDACTONE (View Aldactone Review and Aldactone Label ), HYPEN (View Hypen Review and Hypen Label ), BONALON (View Bonalon Review and Bonalon Label ).

6791176-X | Chronic Myeloid Leukaemia, Focal Segmental Glomerulosclerosis, Leukaemic Infiltration
Adverse event was reported on Jun 15, 2010 by a Female patient taking Fludara (View Usage) (Dosage: ) was diagnosed with chronic lymphocytic leukaemia and. Location: JAPAN , 68 years of age, After Fludara was administered, patient had the following side effects: chronic myeloid leukaemia, focal segmental glomerulosclerosis, leukaemic infiltration. During the same period patient was treated with RITUXIMAB(GENETICAL RECOMBINATION) (View Rituximab(genetical Recombination) Review and Rituximab(genetical Recombination) Label ). Patient was hospitalized.

6791091-1 | Diffuse Large B-cell Lymphoma, Pneumocystis Jiroveci Pneumonia, Stress Cardiomyopathy, Ventricular Tachycardia
on Jun 14, 2010 Female patient from JAPAN , 70 years of age, was diagnosed with waldenstrom's macroglobulinaemia, diffuse large b-cell lymphoma and was treated with Fludara (View Usage). Patient experienced the following unwanted or unexpected effects: diffuse large b-cell lymphoma, pneumocystis jiroveci pneumonia, stress cardiomyopathy, ventricular tachycardia. Fludara dosage: 6 Cycles. During the same period patient was treated with RITUXIMAB (4 Cycles) (View Rituximab Review and Rituximab Label ), CYCLOPHOSPHAMIDE (4 Cycles) (View Cyclophosphamide Review and Cyclophosphamide Label ), DOXORUBICIN HCL (4 Cycles) (View Doxorubicin Hcl Review and Doxorubicin Hcl Label ), VINCRISTINE (4 Cycles) (View Vincristine Review and Vincristine Label ), PREDNISOLONE (4 Cycles) (View Prednisolone Review and Prednisolone Label ).

6789929-7 | Bone Marrow Failure, Cerebral Infarction, Hyperbilirubinaemia, Hypernatraemia
on Jun 16, 2010 Male patient from JAPAN , 72 years of age, was diagnosed with mantle cell lymphoma stage iv, hypoalbuminaemia, hyperglycaemia and was treated with Fludara (View Usage). Patient had the following side effects: bone marrow failure, cerebral infarction, hyperbilirubinaemia, hypernatraemia. Fludara dosage: . During the same period patient was treated with ENDOXAN (View Endoxan Review and Endoxan Label ), RITUXAN (View Rituxan Review and Rituxan Label ), NOVANTRONE (View Novantrone Review and Novantrone Label ), DECADRON (View Decadron Review and Decadron Label ), ALBUMIN (HUMAN) (View Albumin (human) Review and Albumin (human) Label ), NOVOLIN R (As Used: 10-20 Iu) (View Novolin R Review and Novolin R Label ). Patient was hospitalized.

6785688-2 | Coordination Abnormal, Dizziness, Headache
Patient was taking Fludara (View Usage). After Fludara was administered, patient had the following side effects: coordination abnormal, dizziness (What is dizziness?), headache (What is headache?) on Jun 10, 2010 from CANADA Additional patient health information: Male patient , 49 years of age, weighting 178.6 lb, . Fludara dosage: 1 Every 5 Days.

6785587-6 | Bone Marrow Failure, Cerebral Infarction, Hyperbilirubinaemia, Hypernatraemia
Adverse event was reported on Jun 16, 2010 by a Male patient taking Fludara (View Usage) (Dosage: ) was diagnosed with mantle cell lymphoma stage iv, hypoalbuminaemia, hyperglycaemia and. Location: JAPAN , 72 years of age, Patient experienced the following unwanted or unexpected effects: bone marrow failure, cerebral infarction, hyperbilirubinaemia, hypernatraemia. During the same period patient was treated with ENDOXAN (View Endoxan Review and Endoxan Label ), RITUXAN (View Rituxan Review and Rituxan Label ), NOVANTRONE (View Novantrone Review and Novantrone Label ), DECADRON (View Decadron Review and Decadron Label ), ALBUMIN (HUMAN) (View Albumin (human) Review and Albumin (human) Label ), NOVOLIN R (As Used: 10-20 Iu) (View Novolin R Review and Novolin R Label ). Patient was hospitalized.

6784134-2 | Haemothorax, Pulmonary Haemorrhage
on Jun 09, 2010 Male patient from JAPAN , 75 years of age, was diagnosed with chronic lymphocytic leukaemia and was treated with Fludara (View Usage). Patient had the following side effects: haemothorax, pulmonary haemorrhage. Fludara dosage: 1 Course.

6774270-9 | Disseminated Intravascular Coagulation, Neutropenia, Pneumonia, Sepsis
on Jun 04, 2010 Male patient from JAPAN , 78 years of age, was diagnosed with follicle centre lymphoma, follicular grade i, ii, iii stage iv, infection prophylaxis and was treated with Fludara (View Usage). After Fludara was administered, patient had the following side effects: disseminated intravascular coagulation, neutropenia, pneumonia (What is pneumonia?), sepsis (What is sepsis?). Fludara dosage: . During the same period patient was treated with CYCLOPHOSPHAMIDE (View Cyclophosphamide Review and Cyclophosphamide Label ), DOXORUBICIN HCL (View Doxorubicin Hcl Review and Doxorubicin Hcl Label ), VINCRISTINE (View Vincristine Review and Vincristine Label ), PREDNISOLONE (View Prednisolone Review and Prednisolone Label ), RITUXIMAB (View Rituximab Review and Rituximab Label ), DIFLUCAN (View Diflucan Review and Diflucan Label ). Patient was hospitalized.

6771212-7 | Pulmonary Embolism
Patient was taking Fludara (View Usage). Patient experienced the following unwanted or unexpected effects: pulmonary embolism (What is pulmonary embolism?) on Jun 07, 2010 from JAPAN Additional patient health information: Female patient , 52 years of age, was diagnosed with follicle centre lymphoma, follicular grade i, ii, iii and. Fludara dosage: . During the same period patient was treated with HEPARIN AND PREPARATIONS (View Heparin And Preparations Review and Heparin And Preparations Label ), CYCLOPHOSPHAMIDE (View Cyclophosphamide Review and Cyclophosphamide Label ).

6771205-X | Disseminated Intravascular Coagulation, Neutropenia, Pneumonia
Adverse event was reported on Jun 04, 2010 by a Male patient taking Fludara (View Usage) (Dosage: ) was diagnosed with follicle centre lymphoma, follicular grade i, ii, iii stage iv, infection prophylaxis and. Location: JAPAN , 79 years of age, Patient had the following side effects: disseminated intravascular coagulation, neutropenia, pneumonia (What is pneumonia?). During the same period patient was treated with RITUXAN (View Rituxan Review and Rituxan Label ), DIFLUCAN (View Diflucan Review and Diflucan Label ). Patient was hospitalized.

6771157-2 | Myocardial Infarction
on Jun 02, 2010 Male patient from BRAZIL , 47 years of age, was diagnosed with chronic lymphocytic leukaemia and was treated with Fludara (View Usage). After Fludara was administered, patient had the following side effects: myocardial infarction. Fludara dosage: . During the same period patient was treated with CYCLOPHOSPHAMIDE (View Cyclophosphamide Review and Cyclophosphamide Label ), ONDANSETRON (View Ondansetron Review and Ondansetron Label ).

6769595-7 | Cerebral Haemorrhage, Thrombocytopenia
on Jun 04, 2010 Female patient from UNITED STATES , 38 years of age, was diagnosed with chronic myeloid leukaemia and was treated with Fludara (View Usage). Patient experienced the following unwanted or unexpected effects: cerebral haemorrhage, thrombocytopenia. Fludara dosage: As Used: 80 Mg. During the same period patient was treated with NEUPOGEN (As Used: 780 ?g) (View Neupogen Review and Neupogen Label ), MOZOBIL (As Used: 112 Mg) (View Mozobil Review and Mozobil Label ), BUSULFEX (As Used: 230 Mg) (View Busulfex Review and Busulfex Label ), ANTI THYMOCYTE GLOBULIN NOS (Total Daily Dose: 46 Mg) (View Anti-thymocyte Globulin Nos Review and Anti-thymocyte Globulin Nos Label ), ANTI THYMOCYTE GLOBULIN NOS (Total Daily Dose: 138 Mg) (View Anti-thymocyte Globulin Nos Review and Anti-thymocyte Globulin Nos Label ), ANTI THYMOCYTE GLOBULIN NOS (Total Daily Dose: 184 Mg) (View Anti-thymocyte Globulin Nos Review and Anti-thymocyte Globulin Nos Label ), ACYCLOVIR (Total Daily Dose: 800 Mg) (View Acyclovir Review and Acyclovir Label ), PHYTONADIONE (Total Daily Dose: 10 Mg) (View Phytonadione Review and Phytonadione Label ). Patient was hospitalized.

6769227-8 | Acute Graft Versus Host Disease, Encephalopathy, Neuropathy Peripheral, Staphylococcal Sepsis
Patient was taking Fludara (View Usage). Patient had the following side effects: acute graft versus host disease, encephalopathy, neuropathy peripheral, staphylococcal sepsis on Jun 01, 2010 from JAPAN Additional patient health information: Female patient , 68 years of age, was diagnosed with prophylaxis against graft versus host disease and. Fludara dosage: 125 Mg/m2/day. During the same period patient was treated with MELPHALAN HYDROCHLORIDE (View Melphalan Hydrochloride Review and Melphalan Hydrochloride Label ), TACROLIMUS HYDRATE (View Tacrolimus Hydrate Review and Tacrolimus Hydrate Label ), CORTICOSTEROID (View Corticosteroid Review and Corticosteroid Label ). Patient was hospitalized.

6769226-6 | Asthenia, Balance Disorder, Drop Attacks, Vestibular Disorder
Adverse event was reported on Jun 01, 2010 by a Female patient taking Fludara (View Usage) (Dosage: ) was diagnosed with chronic lymphocytic leukaemia and. Location: UNITED KINGDOM , 76 years of age, After Fludara was administered, patient had the following side effects: asthenia, balance disorder, drop attacks, vestibular disorder.

6765740-8 | Disseminated Intravascular Coagulation, Neutropenia, Pneumonia, Sepsis
on Jun 04, 2010 Male patient from JAPAN , 78 years of age, was diagnosed with follicle centre lymphoma, follicular grade i, ii, iii stage iv, infection prophylaxis and was treated with Fludara (View Usage). Patient experienced the following unwanted or unexpected effects: disseminated intravascular coagulation, neutropenia, pneumonia (What is pneumonia?), sepsis (What is sepsis?). Fludara dosage: . During the same period patient was treated with CYCLOPHOSPHAMIDE (View Cyclophosphamide Review and Cyclophosphamide Label ), DOXORUBICIN HCL (View Doxorubicin Hcl Review and Doxorubicin Hcl Label ), VINCRISTINE (View Vincristine Review and Vincristine Label ), PREDNISOLONE (View Prednisolone Review and Prednisolone Label ), RITUXIMAB (View Rituximab Review and Rituximab Label ), DIFLUCAN (View Diflucan Review and Diflucan Label ). Patient was hospitalized.

6762105-X | Gastrointestinal Haemorrhage, Histiocytosis Haematophagic
on May 26, 2010 Male patient from JAPAN , 18 years of age, was diagnosed with stem cell transplant, bone marrow transplant (What is bone marrow transplant?), prophylaxis against graft versus host disease and was treated with Fludara (View Usage). Patient had the following side effects: gastrointestinal haemorrhage, histiocytosis haematophagic. Fludara dosage: Total Daily Dose: 30 Mg/m2 Unit Dose: 50 Mg. During the same period patient was treated with MELPHALAN HYDROCHLORIDE (Total Daily Dose: 90 Mg/m2) (View Melphalan Hydrochloride Review and Melphalan Hydrochloride Label ), ANTI HUMAN THYMOCYTE IMMUNOGLOBULIN,RABBIT (Total Daily Dose: 15 Mg/m2) (View Anti-human Thymocyte Immunoglobulin,rabbit Review and Anti-human Thymocyte Immunoglobulin,rabbit Label ), TACROLIMUS HYDRATE (View Tacrolimus Hydrate Review and Tacrolimus Hydrate Label ), METHOTREXATE (View Methotrexate Review and Methotrexate Label ).

6762104-8 | Haemorrhage Intracranial, Histiocytosis Haematophagic, Thrombotic Microangiopathy
Patient was taking Fludara (View Usage). After Fludara was administered, patient had the following side effects: haemorrhage intracranial, histiocytosis haematophagic, thrombotic microangiopathy on May 26, 2010 from JAPAN Additional patient health information: Male patient , child 4 years of age, was diagnosed with stem cell transplant, bone marrow transplant (What is bone marrow transplant?), prophylaxis against graft versus host disease and. Fludara dosage: Total Daily Dose: 30 Mg/m2. During the same period patient was treated with MELPHALAN HYDROCHLORIDE (Total Daily Dose: 90 Mg/m2) (View Melphalan Hydrochloride Review and Melphalan Hydrochloride Label ), TACROLIMUS HYDRATE (View Tacrolimus Hydrate Review and Tacrolimus Hydrate Label ), METHOTREXATE (View Methotrexate Review and Methotrexate Label ).

6762103-6 | Haemorrhage Intracranial, Histiocytosis Haematophagic
Adverse event was reported on May 26, 2010 by a Female patient taking Fludara (View Usage) (Dosage: Total Daily Dose: 30 Mg/m2) was diagnosed with stem cell transplant, prophylaxis against graft versus host disease and. Location: JAPAN , 15 years of age, Patient experienced the following unwanted or unexpected effects: haemorrhage intracranial, histiocytosis haematophagic. During the same period patient was treated with MELPHALAN HYDROCHLORIDE (Total Daily Dose: 70 Mg/m2) (View Melphalan Hydrochloride Review and Melphalan Hydrochloride Label ), TACROLIMUS HYDRATE (View Tacrolimus Hydrate Review and Tacrolimus Hydrate Label ), METHOTREXATE (View Methotrexate Review and Methotrexate Label ).

6761975-9 | Cerebral Haemorrhage
on Jun 02, 2010 Female patient from UNITED STATES , 38 years of age, was diagnosed with chronic myeloid leukaemia and was treated with Fludara (View Usage). Patient had the following side effects: cerebral haemorrhage. Fludara dosage: As Used: 80 Mg. During the same period patient was treated with NEUPOGEN (As Used: 780 ?g) (View Neupogen Review and Neupogen Label ), PLERIXAFOR (As Used: 112 Mg) (View Plerixafor Review and Plerixafor Label ), BUSULFEX (As Used: 230 Mg) (View Busulfex Review and Busulfex Label ), ANTI THYMOCYTE GLOBULIN NOS (Total Daily Dose: 46 Mg) (View Anti-thymocyte Globulin Nos Review and Anti-thymocyte Globulin Nos Label ), ANTI THYMOCYTE GLOBULIN NOS (Total Daily Dose: 138 Mg) (View Anti-thymocyte Globulin Nos Review and Anti-thymocyte Globulin Nos Label ), ANTI THYMOCYTE GLOBULIN NOS (Total Daily Dose: 184 Mg) (View Anti-thymocyte Globulin Nos Review and Anti-thymocyte Globulin Nos Label ). Patient was hospitalized.

6759898-4 | Cytomegalovirus Viraemia, Organising Pneumonia
on May 24, 2010 Male patient from JAPAN , 70 years of age, was treated with Fludara (View Usage). After Fludara was administered, patient had the following side effects: cytomegalovirus viraemia, organising pneumonia. Fludara dosage: Hla:two Loci Incompatibility. During the same period patient was treated with MELPHALAN HYDROCHLORIDE (Hla:two Loci Incompatibility) (View Melphalan Hydrochloride Review and Melphalan Hydrochloride Label ), TACROLIMUS HYDRATE (Hla:two Loci Incompatibility) (View Tacrolimus Hydrate Review and Tacrolimus Hydrate Label ), METHOTREXATE (Hla:two Loci Incompatibility) (View Methotrexate Review and Methotrexate Label ).

6758673-4 | Fall, Pyrexia
Patient was taking Fludara (View Usage). Patient experienced the following unwanted or unexpected effects: fall (What is fall?), pyrexia on May 25, 2010 from UNITED STATES Additional patient health information: Female patient , 65 years of age, was diagnosed with acute myeloid leukaemia and. Fludara dosage: Total Daily Dose: 64 Mg. During the same period patient was treated with NEUPOGEN (Total Daily Dose: 600 ?g) (View Neupogen Review and Neupogen Label ), PLERIXAFOR (Total Daily Dose: 13968 ?g) (View Plerixafor Review and Plerixafor Label ), BUSULFEX (Total Daily Dose: 209 Mg) (View Busulfex Review and Busulfex Label ), TRIAMCINOLONE (View Triamcinolone Review and Triamcinolone Label ), ZOFRAN (View Zofran Review and Zofran Label ), BACTRIM (View Bactrim Review and Bactrim Label ), CALCIUM CARBONATE (View Calcium Carbonate Review and Calcium Carbonate Label ), FOLIC ACID (View Folic Acid Review and Folic Acid Label ). Patient was hospitalized.

6755796-0 | Cytomegalovirus Viraemia, Organising Pneumonia
Adverse event was reported on May 24, 2010 by a Male patient taking Fludara (View Usage) (Dosage: Hla:two Loci Incompatibility) . Location: JAPAN , 70 years of age, Patient had the following side effects: cytomegalovirus viraemia, organising pneumonia. During the same period patient was treated with MELPHALAN (Hla:two Loci Incompatibility) (View Melphalan Review and Melphalan Label ), TACROLIMUS HYDRATE (Hla:two Loci Incompatibility) (View Tacrolimus Hydrate Review and Tacrolimus Hydrate Label ), METHOTREXATE (Hla:two Loci Incompatibility) (View Methotrexate Review and Methotrexate Label ).

6743104-0 | Oesophageal Carcinoma
on May 24, 2010 Male patient from JAPAN , 68 years of age, weighting 123.5 lb, was diagnosed with follicle centre lymphoma, follicular grade i, ii, iii stage ii and was treated with Fludara (View Usage). After Fludara was administered, patient had the following side effects: oesophageal carcinoma. Fludara dosage: . During the same period patient was treated with RITUXIMAB (View Rituximab Review and Rituximab Label ).

6743061-7 | Acute Graft Versus Host Disease, Protein-losing Gastroenteropathy, Renal Failure, Respiratory Syncytial Virus Infection
on May 21, 2010 Male patient from JAPAN , 22 years of age, was diagnosed with epstein-barr virus infection and was treated with Fludara (View Usage). Patient experienced the following unwanted or unexpected effects: acute graft versus host disease, protein-losing gastroenteropathy, renal failure, respiratory syncytial virus infection (What is respiratory syncytial virus infection?). Fludara dosage: . During the same period patient was treated with CYCLOPHOSPHAMIDE (View Cyclophosphamide Review and Cyclophosphamide Label ), ETOPOSIDE (View Etoposide Review and Etoposide Label ), ANTILYMPHOCYTE IMMUNOGLOBULIN (RABBIT) (View Antilymphocyte Immunoglobulin (rabbit) Review and Antilymphocyte Immunoglobulin (rabbit) Label ).

6723435-0 | Lymphocyte Count Decreased, Paraneoplastic Pemphigus, Platelet Count Decreased, Pneumonia
Patient was taking Fludara (View Usage). Patient had the following side effects: lymphocyte count decreased, paraneoplastic pemphigus, platelet count decreased, pneumonia (What is pneumonia?) on May 07, 2010 from JAPAN Additional patient health information: Male patient , 54 years of age, was diagnosed with follicle centre lymphoma, follicular grade i, ii, iii stage iii, antifungal prophylaxis and. Fludara dosage: Unit Dose: 10 Mg. During the same period patient was treated with COTRIM (View Cotrim Review and Cotrim Label ). Patient was hospitalized.

6720036-5 | Anaemia, Cytolytic Hepatitis, Herpes Virus Infection, Non-hodgkin's Lymphoma
Adverse event was reported on May 07, 2010 by a Female patient taking Fludara (View Usage) (Dosage: ) was diagnosed with chronic lymphocytic leukaemia and. Location: ROMANIA , 55 years of age, After Fludara was administered, patient had the following side effects: anaemia, cytolytic hepatitis, herpes virus infection, non-hodgkin's lymphoma. During the same period patient was treated with LEUKERAN (View Leukeran Review and Leukeran Label ).

6719055-4 | Histiocytosis Haematophagic, Infection, Thrombotic Microangiopathy
on Apr 28, 2010 Male patient from JAPAN , 59 years of age, was treated with Fludara (View Usage). Patient experienced the following unwanted or unexpected effects: histiocytosis haematophagic, infection (What is infection?), thrombotic microangiopathy. Fludara dosage: Hla: Matched Related Donor. During the same period patient was treated with BUSULFEX (Hla: Matched Related Donor) (View Busulfex Review and Busulfex Label ), IMATINIB MESILATE (View Imatinib Mesilate Review and Imatinib Mesilate Label ), DASATINIB HYDRATE (View Dasatinib Hydrate Review and Dasatinib Hydrate Label ).

6716872-1 | Histiocytosis Haematophagic, Infection, Thrombotic Microangiopathy
on Apr 28, 2010 Male patient from JAPAN , 59 years of age, was treated with Fludara (View Usage). Patient had the following side effects: histiocytosis haematophagic, infection (What is infection?), thrombotic microangiopathy. Fludara dosage: Hla: Matched Related Donor. During the same period patient was treated with BUSULFEX (Hla: Matched Related Donor) (View Busulfex Review and Busulfex Label ), IMATINIB MESILATE (View Imatinib Mesilate Review and Imatinib Mesilate Label ), DASATINIB HYDRATE (View Dasatinib Hydrate Review and Dasatinib Hydrate Label ).

6713263-4 | Agranulocytosis, Alveolitis Allergic, Lymphopenia, Neutropenia
Patient was taking Fludara (View Usage). After Fludara was administered, patient had the following side effects: agranulocytosis, alveolitis allergic, lymphopenia, neutropenia on Apr 27, 2010 from FRANCE Additional patient health information: Female patient , 60 years of age, weighting 172.0 lb, was diagnosed with chronic lymphocytic leukaemia and. Fludara dosage: 6 Courses. During the same period patient was treated with MABTHERA (6 Courses) (View Mabthera Review and Mabthera Label ), ENDOXAN (6 Courses) (View Endoxan Review and Endoxan Label ), NEXIUM (Introduced After Jun-2009) (View Nexium Review and Nexium Label ), KESTIN (Introduced After Jun-2009) (View Kestin Review and Kestin Label ), BACTRIM (View Bactrim Review and Bactrim Label ), PROPRANOLOL (View Propranolol Review and Propranolol Label ), PREDNISONE (View Prednisone Review and Prednisone Label ), ATARAX (View Atarax Review and Atarax Label ). Patient was hospitalized.

6702126-6 | Autoimmune Neutropenia, Autoimmune Thrombocytopenia, Haemolytic Anaemia
Adverse event was reported on Apr 05, 2010 by a Male patient taking Fludara (View Usage) (Dosage: Total Daily Dose: 50 Mg) was diagnosed with chronic lymphocytic leukaemia and. Location: UNITED STATES , 62 years of age, Patient experienced the following unwanted or unexpected effects: autoimmune neutropenia, autoimmune thrombocytopenia, haemolytic anaemia. During the same period patient was treated with RITUXIMAB (View Rituximab Review and Rituximab Label ).

6698244-1 | Dyspnoea, Metabolic Acidosis, Multi-organ Failure, Pericarditis, Platelet Count Decreased, Renal Failure Acute, Renal Impairment, Septic Shock
on Mar 22, 2010 Female patient from UNITED STATES , 43 years of age, weighting 194.0 lb, was diagnosed with acute myeloid leukaemia and was treated with Fludara (View Usage). Patient had the following side effects: dyspnoea, metabolic acidosis, multi-organ failure, pericarditis, platelet count decreased, renal failure acute, renal impairment, septic shock. Fludara dosage: Cycle 3, 30 Mg/m2 X 5/7. During the same period patient was treated with ARA C (Cycle 2) (View Ara-c Review and Ara-c Label ), ARA C (Cycle 4) (View Ara-c Review and Ara-c Label ), ARA C (Cycle 3, 2 Mg/m2 X 5/7) (View Ara-c Review and Ara-c Label ), ARA C (Cycle 1 Standard Aml Protocol) (View Ara-c Review and Ara-c Label ), NEUPOGEN (30 Miu/day Till Count Recovery) (View Neupogen Review and Neupogen Label ), ZAVEDOS (Day 1-3) (View Zavedos Review and Zavedos Label ), EVOLTRA (Cycle 2) (View Evoltra Review and Evoltra Label ). Patient was hospitalized.

6687942-1 | Venoocclusive Liver Disease
on Apr 08, 2010 Female patient from JAPAN , 44 years of age, was diagnosed with acute lymphocytic leukaemia, prophylaxis against graft versus host disease and was treated with Fludara (View Usage). After Fludara was administered, patient had the following side effects: venoocclusive liver disease. Fludara dosage: . During the same period patient was treated with MELPHALAN HYDROCHLORIDE (View Melphalan Hydrochloride Review and Melphalan Hydrochloride Label ), TACROLIMUS (View Tacrolimus Review and Tacrolimus Label ), MYCOPHENOLATE MOFETIL (View Mycophenolate Mofetil Review and Mycophenolate Mofetil Label ).

6679295-X | Pulmonary Embolism
Patient was taking Fludara (View Usage). Patient experienced the following unwanted or unexpected effects: pulmonary embolism (What is pulmonary embolism?) on Apr 07, 2010 from JAPAN Additional patient health information: Female patient , 52 years of age, was diagnosed with follicle centre lymphoma, follicular grade i, ii, iii and. Fludara dosage: . During the same period patient was treated with HEPARIN AND PREPARATIONS (View Heparin And Preparations Review and Heparin And Preparations Label ), CYCLOPHOSPHAMIDE (View Cyclophosphamide Review and Cyclophosphamide Label ).

6679244-4 | Autoimmune Neutropenia, Autoimmune Thrombocytopenia, Haemolytic Anaemia
Adverse event was reported on Apr 05, 2010 by a Male patient taking Fludara (View Usage) (Dosage: Total Daily Dose: 50 Mg) was diagnosed with chronic lymphocytic leukaemia and. Location: UNITED STATES , 62 years of age, Patient had the following side effects: autoimmune neutropenia, autoimmune thrombocytopenia, haemolytic anaemia. During the same period patient was treated with RITUXIMAB (View Rituximab Review and Rituximab Label ).

6669030-3 | Chronic Myeloid Leukaemia Transformation, Focal Segmental Glomerulosclerosis, Leukaemic Infiltration
on Mar 31, 2010 Female patient from JAPAN , 68 years of age, was diagnosed with chronic lymphocytic leukaemia and was treated with Fludara (View Usage). After Fludara was administered, patient had the following side effects: chronic myeloid leukaemia transformation, focal segmental glomerulosclerosis, leukaemic infiltration. Fludara dosage: . During the same period patient was treated with RITUXIMAB(GENETICAL RECOMBINATION) (View Rituximab(genetical Recombination) Review and Rituximab(genetical Recombination) Label ). Patient was hospitalized.

6668781-4 | Aspartate Aminotransferase Increased, Varicella
on Apr 01, 2010 Female patient from JAPAN , 65 years of age, was diagnosed with splenic marginal zone lymphoma stage iv, sinusitis (What is sinusitis?), hepatitis b (What is hepatitis b?) and was treated with Fludara (View Usage). Patient experienced the following unwanted or unexpected effects: aspartate aminotransferase increased, varicella. Fludara dosage: Unit Dose: 10 Mg. During the same period patient was treated with VFEND (View Vfend Review and Vfend Label ), BARACLUDE (View Baraclude Review and Baraclude Label ).

6668619-5 | Dyspnoea, Metabolic Acidosis, Multi-organ Failure, Pericarditis, Renal Failure Acute, Renal Impairment, Septic Shock
Patient was taking Fludara (View Usage). Patient had the following side effects: dyspnoea, metabolic acidosis, multi-organ failure, pericarditis, renal failure acute, renal impairment, septic shock on Mar 22, 2010 from UNITED STATES Additional patient health information: Female patient , 43 years of age, weighting 194.0 lb, was diagnosed with acute myeloid leukaemia and. Fludara dosage: Cycle 3, 30 Mg/m2 X 5/7. During the same period patient was treated with ARA C (Cycle 1 Standard Aml Protocol) (View Ara-c Review and Ara-c Label ), ARA C (Cycle 3, 2 Mg/m2 X 5/7) (View Ara-c Review and Ara-c Label ), ARA C (Cycle 4) (View Ara-c Review and Ara-c Label ), ARA C (Cycle 2) (View Ara-c Review and Ara-c Label ), NEUPOGEN (30 Miu/day Till Count Recovery) (View Neupogen Review and Neupogen Label ), ZAVEDOS (Day 1-3) (View Zavedos Review and Zavedos Label ), EVOLTRA (Cycle 2) (View Evoltra Review and Evoltra Label ). Patient was hospitalized.